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SCREWFIX

739099

Class IIaMDDOn the marketSingle useSterile

Manufacturer: BIOPSYBELL SRL
Manufacturer SRN: IT-MF-000011601
UDI-DI: 08033860038861
Basic UDI-DI: B-08033860038861
Reference: 739099
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 05.08.2026 14:49

Manufacturer products View details

ORTHOPLASTY

SUBFIL1315C-EM

Class IIaMDDOn the marketSingle useSterile

Manufacturer: BIOPSYBELL SRL
Manufacturer SRN: IT-MF-000011601
UDI-DI: 08033860037192
Basic UDI-DI: B-08033860037192
Reference: SUBFIL1315C-EM
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 05.08.2026 14:49

Manufacturer products View details

SCREWFIX

SF1118.501C1D

Class IIaMDDOn the marketSingle useSterile

Manufacturer: BIOPSYBELL SRL
Manufacturer SRN: IT-MF-000011601
UDI-DI: 08033860025519
Basic UDI-DI: B-08033860025519
Reference: SF1118.501C1D
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 05.08.2026 14:49

Manufacturer products View details

HPS™ 2.0

HPS™ Cement injection set

Class IIaMDDOn the marketReusable

Manufacturer: Paradigm Spine GmbH
Manufacturer SRN: DE-MF-000011231
UDI-DI: 04260148899232
Basic UDI-DI: B-04260148899232
Reference: HCD80800
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:13

Manufacturer products View details

04250539902283

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: HumanTech Spine GmbH
Manufacturer SRN: DE-MF-000010596
UDI-DI: 04250539902283
Basic UDI-DI: B-04250539902283
Reference: 1006020603
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:30

Manufacturer products View details

PALABOWL ® Bone Cement Mixing System

CL006-01

Class IMDDOn the marketSingle useSterile

Manufacturer: Guangzhou Clean Medical Products Manufacturing Corp.
Manufacturer SRN: CN-MF-000008926
UDI-DI: 06951233720897
Basic UDI-DI: B-06951233720897
Reference: 5050166
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

KAM-Bolzenset (2 Stück)

KAM Screw M6; KAM-Bolt

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: Peter Brehm GmbH
Manufacturer SRN: DE-MF-000006458
UDI-DI: 04051308013021
Basic UDI-DI: 4029839PB000006883
Reference: 98180-04-00
EMDN: P099003
EMDN description: ORTHOPAEDIC PROSTHESES FIXING ELEMENTS - NOT OTHERWISE CLASSIFIED
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:18

Manufacturer products View details

Kniearthrodesenmodul neutral

KAM Packaging Unit Knee Arthrodesis Module

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: Peter Brehm GmbH
Manufacturer SRN: DE-MF-000006458
UDI-DI: 04029839983588
Basic UDI-DI: 4029839PB00000167G
Reference: 98180-00
EMDN: P099003
EMDN description: ORTHOPAEDIC PROSTHESES FIXING ELEMENTS - NOT OTHERWISE CLASSIFIED
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:13

Manufacturer products View details

Prothesenschaft gerade zementiert

KAM Titanium Stem Straight Cemented

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: Peter Brehm GmbH
Manufacturer SRN: DE-MF-000006458
UDI-DI: 04029839606371
Basic UDI-DI: 4029839PB000006985
Reference: 60912-11
EMDN: P099003
EMDN description: ORTHOPAEDIC PROSTHESES FIXING ELEMENTS - NOT OTHERWISE CLASSIFIED
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:13

Manufacturer products View details

Tibia-Arthrodesenmodulhälfte

KAM Femur / Tibia Arthrodesis Component

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: Peter Brehm GmbH
Manufacturer SRN: DE-MF-000006458
UDI-DI: 04029839988590
Basic UDI-DI: 4029839PB00000077F
Reference: 98180-102
EMDN: P099003
EMDN description: ORTHOPAEDIC PROSTHESES FIXING ELEMENTS - NOT OTHERWISE CLASSIFIED
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:13

Manufacturer products View details

OGM® 3A

1453/LG

Class IIIMDDOn the marketImplantableMedicinal productSingle useSterile

Manufacturer: Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ
Manufacturer SRN: TR-MF-000021263
UDI-DI: 08682024000123
Basic UDI-DI: B-08682024000123
Reference: 1453/LG
EMDN: P099001
EMDN description: ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 08:29

Manufacturer products View details

OGM® 1A

1071/SG

Class IIIMDDOn the marketImplantableMedicinal productSingle useSterile

Manufacturer: Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ
Manufacturer SRN: TR-MF-000021263
UDI-DI: 08682024000116
Basic UDI-DI: B-08682024000116
Reference: 1071/SG
EMDN: P099001
EMDN description: ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 08:28

Manufacturer products View details

OGM® 3A

1810/LG

Class IIIMDDOn the marketImplantableMedicinal productSingle useSterile

Manufacturer: Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ
Manufacturer SRN: TR-MF-000021263
UDI-DI: 08682024000086
Basic UDI-DI: B-08682024000086
Reference: 1810/LG
EMDN: P099001
EMDN description: ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 08:28

Manufacturer products View details

OGM® 1A

1711/SG

Class IIIMDDOn the marketImplantableMedicinal productSingle useSterile

Manufacturer: Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ
Manufacturer SRN: TR-MF-000021263
UDI-DI: 08682024000079
Basic UDI-DI: B-08682024000079
Reference: 1711/SG
EMDN: P099001
EMDN description: ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 08:28

Manufacturer products View details

OGM® 3A

1503/LG

Class IIIMDDOn the marketAdministering medicineImplantableMedicinal productSingle useSterile

Manufacturer: Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ
Manufacturer SRN: TR-MF-000021263
UDI-DI: 08682024000048
Basic UDI-DI: B-08682024000048
Reference: 1503/LG
EMDN: P099001
EMDN description: ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 08:28

Manufacturer products View details

OGM® 1A

1506/SG

Class IIIMDDOn the marketImplantableMedicinal productSingle useSterile

Manufacturer: Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ
Manufacturer SRN: TR-MF-000021263
UDI-DI: 08682024000031
Basic UDI-DI: B-08682024000031
Reference: 1506/SG
EMDN: P099001
EMDN description: ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 08:28

Manufacturer products View details

EASYMIX® bowl

CL006-01

Class IMDDOn the marketSingle useSterile

Manufacturer: Guangzhou Clean Medical Products Manufacturing Corp.
Manufacturer SRN: CN-MF-000008926
UDI-DI: 06951233720644
Basic UDI-DI: B-06951233720644
Reference: LD2000
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

MIXY

KTYMIX

Class IMDDOn the marketSingle useSterile

Manufacturer: BIOPSYBELL SRL
Manufacturer SRN: IT-MF-000011601
UDI-DI: 08033860046620
Basic UDI-DI: B-08033860046620
Reference: KTYMIX
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 04.08.2026 03:56

Manufacturer products View details

P-INJECT

P-INJECT1

Class IMDDOn the marketSingle useSterile

Manufacturer: BIOPSYBELL SRL
Manufacturer SRN: IT-MF-000011601
UDI-DI: 08033860045333
Basic UDI-DI: B-08033860045333
Reference: P-INJECT1
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 04.08.2026 03:56

Manufacturer products View details

SCREWFIX

KKSF0920021D

Class IIaMDDOn the marketSingle useSterile

Manufacturer: BIOPSYBELL SRL
Manufacturer SRN: IT-MF-000011601
UDI-DI: 08033860044879
Basic UDI-DI: B-08033860044879
Reference: KKSF0920021D
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 04.08.2026 03:56

Manufacturer products View details